More Intensive Cardiac Rehabilitation Programs in Less Time (másPORmenos)

June 5, 2018 updated by: Almudena Castro Conde

Multicenter, Prospective, Randomized, Open, Blinded for the End Point Evaluator to Compare Compliance to Secondary Prevention Measures After Acute Coronary Syndrome and Intensive Cardiac Rehabilitation Program vs Standard Program

To determine if an intensive cardiac rehabilitation program with periodic reinforcements improve the compliance/adherence to secondary preventive measures (physical exercise, mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary syndrome with or without ST segment elevation versus an standard cardiac rehabilitation program

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

509

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 08046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Equal or older 18 years old
  • Acute coronary syndrome with or without ST elevation within last two months
  • Being able to do physical exercise
  • Being able to understand the educative sessions
  • Being able to understand patient information in the consent form

Exclusion Criteria:

  • Hemodynamic instability
  • Left ventricular ejection fraction (LVEF) < or = 35%
  • Heart failure class III -IV (New York Heart Association (NYHA) Functional Classification)
  • Refractory angina
  • Any pathology for which physical exercise is not indicated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intensivo
intensive cardiac rehabilitation program in less time
Other: Intensive cardiac rehabilitation program in less time
2 weeks, 5 days a week, and reinforcement sessions at 3, 6 and 9 months
No Intervention: Convencional
standard cardiac rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to physical exercise
Time Frame: baseline-12 months
Assessed in Metabolic Equivalents of Task (METS) from baseline by ergometry
baseline-12 months
Adherence to Mediterranean diet
Time Frame: baseline-12 months
Assessed by Mediterranean diet adherence questionnaire (Modified Trichopoulou A,)
baseline-12 months
Tabacco abstinence
Time Frame: baseline-12 months
Assessed by cooximetry (less dan 10 ppm)
baseline-12 months
Number of participants reporting compliance with prescribed treatments
Time Frame: baseline-12 months
Patient-reported answers form the investigator
baseline-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Almudena Castro Conde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

October 4, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • másPORmenos

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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